Download 3-110 Card Technical Information Report Active implantable medical

Technical Information Report
Active implantable medical devices
- Guidance for designation of left
ventricle and implantable
3Card cardioverter defibrillator lead
TIR41:2011 01/15/2013 AAMI
110
connectors and pulse generator
connector cavities for implantable
pacemakers and implantable
cardioverter defibrillators
Recognition List Number: 030 Publication Date: 01/15/2013
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 3-110: AAMI TIR41:2011, Technical Information Report Active
implantable medical devices - Guidance for designation of left ventricle and
implantable cardioverter defibrillator lead connectors and pulse generator connector
cavities for implantable pacemakers and implantable cardioverter defibrillators.
(Cardiovascular)
Date of Standard: 2011.
Address of Standards Organization:
Association for the Advancement of Medical Instrumentation (AAMI)
4301 North Fairfax Drive
Suite 301
Arlington, VA 22203
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
DIVISION OF CARDIOVASCULAR DEVICES (DCD)
Devices Affected:
Implantable pacemakers, pacemaker lead and pacemaker lead adapters
Processes Affected:
PMA, PDP, IDE, HDE, Quality System Regulation
Type of Standard:
Vertical, International
Extent of Recognition:
Complete Standard
Related CFR Citations and Product Codes:
Regulation
Device Name
Number
Unclassified Defibrillator, Automatic Implantable Cardioverter, With Cardiac
Device
Class
Product
Code
Class 3 NIK21
Resynchronization (Crt-D)
Unclassified Defibrillator, Implantable, Dual-Chamber
Class 3 MRM22
Unclassified Implantable Cardioverter Defibrillator (Non-Crt)
Class 3 LWS23
Unclassified Implantable Pulse Generator, Pacemaker (Non-Crt)
Class 3 LWP24
Unclassified Pulse Generator, Pacemaker, Implantable, With Cardiac
Class 3 NKE25
Resynchronization (Crt-P)
Unclassified Pulse Generator, Permanent, Implantable
Class 3 NVZ26
Unclassified Pulse-Generator, Single Chamber, Sensor Driven, Implantable
Class 3 LWO27
Unclassified Pulse-Generator, Single Chamber, Single
Class 3 LWW28
§870.361029
Class 3 DXY30
Implantable Pacemaker Pulse-Generator
Relevant Guidance:
There is no relevant guidance developed at this time.
[Code of Federal Regulations]
[Title 21, Volume 8]
8
[Revised as of April 1, 2013]
[CITE: 21CFR870.3610]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 870 -- CARDIOVASCULAR DEVICES
Subpart D--Cardiovascular Prosthetic Devices
Sec. 870.3610 Implantable pacemaker pulse generator.
(a)Identification. An implantable pacemaker pulse generator is a
device that has a power supply and electronic circuits that
produce a periodic electrical pulse to stimulate the heart. This
device is used as a substitute for the heart's intrinsic pacing
system to correct both intermittent and continuous cardiac rhythm
disorders. This device may include triggered, inhibited, and
asynchronous modes and is implanted in the human body.
(b)Classification. Class III (premarket approval).
(c)Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the
Food and Drug Administration on or before September 20, 2012, for
any implantable pacemaker pulse generator device that was in
commercial distribution before May 28, 1976, or that has, on or
before September 20, 2012, been found to be substantially
equivalent to any implantable pacemaker pulse generator device
that was in commercial distribution before May 28, 1976. Any other
implantable pacemaker pulse generator device shall have an
approved PMA or declared completed PDP in effect before being
placed in commercial distribution.
[45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11,
1987; 77 FR 37576, June 22, 2012]